Ultrasound in AscitesNCT07196553
Ultrasound and Ascites
An observational study of Ultrasound in Ascites, run by Assiut University.
Trial summary
The aim of this study is to evaluate the role of ultrasound in the detection, characterization, and determination of the underlying cause of ascites in patients attending Assiut University Hospital Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ultrasound in Ascites
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2027
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: -Patients attending Assiut University Hospital from different age groups and both sexex with clinically suspected ascites referred for abdominal ultrasound.
Who may be able to join
- Patient from different age groups and both sexex will be included in our study.
- Patients with clinically suspected ascites referred for abdominal ultrasound.
- Patients who will provide informed consent for participation.
Who cannot join
- Patients with a history of recent abdominal surgery (<1 month).
- Patients with inadequate ultrasound visualization due to severe obesity or extensive bowel gas.
- Patients who will decline to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Role of Ultrasound in Ascites: Detection, Characterization, and Evaluation of the Underlying Cause.
The aim of this study is to evaluate the role of ultrasound in the detection, characterization, and determination of the underlying cause of ascites in patients attending Assiut University Hospital
Read the detailed description
Normally, the peritoneal cavity contains 25-50 mL of ascitic fluid, which allows for the movement of bowel loops past one other and helps hydrate serosal surfaces. Ascites is defined as the pathological accumulation of excess fluid in the peritoneal cavity.
More than one cause may be responsible for the development of ascites (multifactorial), liver cirrhosis remains the leading cause (≈85% of cases), followed by many causes such as malignant neoplasia, tuberculous infection, cardiac insufficiency, renal diseases ,trauma and other infectious, inflammatory and hemorrhagic causes ,multiple etiologies may coexist.
once ascites develops, it carries a risk of further serious complications such as acute spontaneous bacterial peritonitis (SBP) (Occurs in 10-30% of hospitalized cirrhotic patients with ascites and associated with high morbidity and mortality rate), hepatorenal syndrome, hepatic hydrothorax, respiratory compromise and other compliactions including gastrointestinal, circulatory , metabolic complications….etc Medical history, physical examination, abdominal ultrasound, blood tests, and a diagnostic paracentesis for ascitic fluid analysis should all be part of the initial assessment of ascites. Ascites can be detected on physical examination using traditional shifting dullness to percussion when there is approximately 500 ml of fluid. However, in an increasingly obese population, there is limited reliability on clinical examination findings alone.
Trans-abdominal US (TAUS) can easily demonstrate large volumes of fluid and, with a meticulous technique, much smaller volumes can also be detected making an excellent first-line imaging tool, safe, inexpensive, and widely available, It's also superior to CT in qualitative assessment-distinguishing between simple (anechoic) and complex (particulate or septated) ascites.Portable ultrasound devices further enable reliable, bedside diagnosis.
Ultrasound is also used in ultrasound-guided aspiration and paracentesis which is essential for safely obtaining ascitic fluid for determining the underlying etiology (via Serum-Ascites Albumin Gradient (SAAG), cytology, biochemical analysis) and detecting complications such as spontaneous bacterial peritonitis,The presence of septations or debris in ascites fluid can be suggestive of infected ascites.
The most important diagnostic study of any patient being evaluated for SBP or being admitted to the hospital with ascites and cirrhosis is a paracentesis. In a US national inpatient study of over 31,000 patients admitted with cirrhosis and ascites where about one-half underwent a paracentesis, the mortality rate for patients who underwent a paracentesis was significantly lower than for those who did not have one (6.3% vs 8.9%). hemorrhagic ascites, or malignant recurrence.
Real-time ultrasound improves diagnostic accuracy and reduces complication rates compared with landmark-based aspiration..Using ultrasound guidance for paracentesis significantly reduces complication rates, such as bleeding and infection.complication rates drop from ~4.7% (landmark-based) to ~1.4% with ultrasound.
therapeutic paracentesis is established as the first-line treatment for patients with large or refractory ascites providing rapid symptom relief and improving quality of life. It is safe when done under ultrasound guidance with albumin replacement for large-volume drainage.
' We chose to carry out this study to evaluate the specificity, sensitivity, accuracy, and positive and negative predictive value of role of ultrasound in detection of ascites and evaluation of the underlying cause.
- Conditions
- Ultrasound in Ascites
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
ultrasound examination
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of ultrasound in ascites
To evaluate the accuracy of ultrasound in ascites detection and characterization.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound in AscitesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mohamed Sayed Abdelaziz, Assiut University
- Investigators
- Sami Abdel-Aziz Khalil, proffesor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196553
- Sponsor's protocol ID
- Role of ultrasound in ascites
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasound in Ascites: Detection, Characterization, and Evaluation of the Underlying Cause.
- ClinicalTrials.gov ID
- NCT07196553
- Acronym / sponsor ID
- Role of ultrasound in ascites
- Conditions
- Ultrasound in Ascites
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the role of ultrasound in the detection, characterization, and determination of the underlying cause of ascites in patients attending Assiut University Hospital
Detailed description
Normally, the peritoneal cavity contains 25-50 mL of ascitic fluid, which allows for the movement of bowel loops past one other and helps hydrate serosal surfaces. Ascites is defined as the pathological accumulation of excess fluid in the peritoneal cavity.
More than one cause may be responsible for the development of ascites (multifactorial), liver cirrhosis remains the leading cause (≈85% of cases), followed by many causes such as malignant neoplasia, tuberculous infection, cardiac insufficiency, renal diseases ,trauma and other infectious, inflammatory and hemorrhagic causes ,multiple etiologies may coexist.
once ascites develops, it carries a risk of further serious complications such as acute spontaneous bacterial peritonitis (SBP) (Occurs in 10-30% of hospitalized cirrhotic patients with ascites and associated with high morbidity and mortality rate), hepatorenal syndrome, hepatic hydrothorax, respiratory compromise and other compliactions including gastrointestinal, circulatory , metabolic complications….etc Medical history, physical examination, abdominal ultrasound, blood tests, and a diagnostic paracentesis for ascitic fluid analysis should all be part of the initial assessment of ascites. Ascites can be detected on physical examination using traditional shifting dullness to percussion when there is approximately 500 ml of fluid. However, in an increasingly obese population, there is limited reliability on clinical examination findings alone.
Trans-abdominal US (TAUS) can easily demonstrate large volumes of fluid and, with a meticulous technique, much smaller volumes can also be detected making an excellent first-line imaging tool, safe, inexpensive, and widely available, It's also superior to CT in qualitative assessment-distinguishing between simple (anechoic) and complex (particulate or septated) ascites.Portable ultrasound devices further enable reliable, bedside diagnosis.
Ultrasound is also used in ultrasound-guided aspiration and paracentesis which is essential for safely obtaining ascitic fluid for determining the underlying etiology (via Serum-Ascites Albumin Gradient (SAAG), cytology, biochemical analysis) and detecting complications such as spontaneous bacterial peritonitis,The presence of septations or debris in ascites fluid can be suggestive of infected ascites.
The most important diagnostic study of any patient being evaluated for SBP or being admitted to the hospital with ascites and cirrhosis is a paracentesis. In a US national inpatient study of over 31,000 patients admitted with cirrhosis and ascites where about one-half underwent a paracentesis, the mortality rate for patients who underwent a paracentesis was significantly lower than for those who did not have one (6.3% vs 8.9%). hemorrhagic ascites, or malignant recurrence.
Real-time ultrasound improves diagnostic accuracy and reduces complication rates compared with landmark-based aspiration..Using ultrasound guidance for paracentesis significantly reduces complication rates, such as bleeding and infection.complication rates drop from ~4.7% (landmark-based) to ~1.4% with ultrasound.
therapeutic paracentesis is established as the first-line treatment for patients with large or refractory ascites providing rapid symptom relief and improving quality of life. It is safe when done under ultrasound guidance with albumin replacement for large-volume drainage.
' We chose to carry out this study to evaluate the specificity, sensitivity, accuracy, and positive and negative predictive value of role of ultrasound in detection of ascites and evaluation of the underlying cause.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- -Patients attending Assiut University Hospital from different age groups and both sexex with clinically suspected ascites referred for abdominal ultrasound.
Key inclusion criteria (3 listed)
- Patient from different age groups and both sexex will be included in our study.
- Patients with clinically suspected ascites referred for abdominal ultrasound.
- Patients who will provide informed consent for participation.
Key exclusion criteria (3 listed)
- Patients with a history of recent abdominal surgery (<1 month).
- Patients with inadequate ultrasound visualization due to severe obesity or extensive bowel gas.
- Patients who will decline to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasoundultrasound examination | Device | – |
Primary outcome
Role of ultrasound in ascites
Time frame: Baseline
To evaluate the accuracy of ultrasound in ascites detection and characterization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Ultrasound Assessment of Diaphragmatic Structure and Function in Patients With Liver Cirrhosis: A Point-of-Care Tool for Predicting Complications and Sarcopenia in Limited Resource Settings
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sami Abdel-Aziz Khalil, proffesor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound in Ascites, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa Mohamed Abdelaziz (+201015039486, es2011es99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of ultrasound in ascites (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.